Suppliers and packagers for LIPOFEN

LIPOFEN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612	NDA	ANI Pharmaceuticals, Inc.	62559-305-90	90 CAPSULE in 1 BOTTLE (62559-305-90)	2021-09-24
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612	NDA	ANI Pharmaceuticals, Inc.	62559-306-90	90 CAPSULE in 1 BOTTLE (62559-306-90)	2021-09-24
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-460-90	90 CAPSULE in 1 BOTTLE (62559-460-90)	2016-04-13

Suppliers and packagers for LIPOFEN

Last updated: May 31, 2026

LIPOFEN (fenofibrate) Suppliers: API Manufacturers, Contract Fill-Finish, and Key Raw-Material Sources

LIPOFEN is a fenofibrate product. Supplier mapping hinges on (1) the active pharmaceutical ingredient (API) manufacturer(s) used by each marketer for the specific strength and dosage form, and (2) the finished-dose packager and critical excipient and packaging suppliers used for that marketed configuration.

No complete, reliable supplier roster can be produced from the information provided.

What is LIPOFEN’s active ingredient and which supply chain segments matter for fenofibrate?

Featured snippet answer: LIPOFEN is fenofibrate, so the supply chain segments are: fenofibrate API, excipients, dose-form primary packaging, and contract manufacturing/packaging (CMO/CDMO) for the finished product.

Fenofibrate supply chain: where IP and compliance concentrate

• API: fenofibrate crystallization, polymorph control, impurity profile control, and documentation under GMP and ICH Q3A/Q3B-aligned impurity strategy.
• Excipients: wetting/disintegration performance for the specific dosage form (tablet/capsule), including binders, disintegrants, lubricants, and film-formers if applicable.
• Packaging: blister (PVC/PVDC/Alu) or bottles (HDPE) plus desiccant where humidity sensitivity requires it.
• Manufacturing: blending, granulation (if needed), compression/coating, sterilization is not typically relevant for fenofibrate oral solids.
• Release testing: assay, related substances, dissolution, water content (as applicable), and stability protocols.

Which companies supply fenofibrate API used in branded products like LIPOFEN?

Featured snippet answer: The API supplier(s) are product-specific and typically disclosed through FDA Drug Master File (DMF) references, Orange Book manufacturing records, and current Good Manufacturing Practice (cGMP) labeling/manufacturer sections for the specific NDA/ANDA strength and dosage form.

Where API supplier identity appears

• FDA labels (listed manufacturer/packager)
• Orange Book “Applicant” and “Patent/Exclusivity” entries do not directly list API suppliers, but they link to the applicant and labeled manufacturing sites.
• DMF holder names and referenced sites in FDA reviews are the most direct path, but they require access to the referenced DMF metadata for the exact listed product.

What suppliers handle LIPOFEN finished-dose manufacturing and packaging?

Featured snippet answer: Finished-dose suppliers are typically the labeled manufacturer and packager on the product label for the exact strength and dosage form. This can vary by geography and by strength.

Finished-dose manufacturing roles

• Drug product manufacturer: tablet/capsule production site.
• Packager/labeled site: blistering/bottling and secondary packaging.
• Quality control release site: often the same as the manufacturing site, sometimes separate.

What excipient suppliers are typical for fenofibrate tablets/capsules?

Featured snippet answer: Excipients for fenofibrate solid oral dosage forms come from commodity pharmaceutical suppliers and are selected for dissolution, compression characteristics, and stability. Without the exact LIPOFEN formulation and strength, specific supplier identities cannot be stated reliably.

Excipients commonly implicated for oral fenofibrate formulations

• Binders (for granulation or tablet integrity)
• Disintegrants (for dissolution rate control)
• Lubricants (for flow and compression)
• Film-coatings (if film-coated)
• Antiadherents and glidants (if used)
• Capsule shell materials (if capsule dosage form)

What packaging suppliers are used for LIPOFEN?

Featured snippet answer: Packaging suppliers depend on whether LIPOFEN is marketed as blister or bottled product and on market-specific requirements. Packaging supplier identity is usually disclosed indirectly via labeled packaging and sometimes via packaging component registrations.

Packaging component categories

• Blister: PVC/PVDC/Alu or equivalent medical-grade film systems
• Bottles: HDPE with induction seal
• Closures: child-resistant caps where required
• Desiccant: only if stability testing indicates moisture risk

Does LIPOFEN have multiple strengths or dosage forms with different suppliers?

Featured snippet answer: Branded fenofibrate products often have strength- and dose-form-specific manufacturing and packaging, which can shift supplier networks between SKUs.

Why strength changes supplier networks

• Different granulation/coating recipes
• Different compression tooling and dissolution targets
• Different packaging configurations (blisters vs bottles)
• Different stability campaigns tied to the exact formulation and primary packaging

How does Orange Book status affect supplier mapping for LIPOFEN in the US?

Featured snippet answer: Orange Book entries help identify the FDA applicant and the NDA/ANDA structure, but do not directly list the API or excipient suppliers. Supplier mapping still requires product label manufacturing data and, for API, DMF-linked manufacturing.

Litigation and exclusivity do not identify suppliers

Paragraph IV and settlement outcomes influence who can market, not which API firm is used by a particular marketer unless tied to labeled manufacturing and DMF references.

What generic entry risks exist for fenofibrate products like LIPOFEN that could shift suppliers?

Featured snippet answer: Generic entry can shift supplier networks if the ANDA applicant uses a different fenofibrate API supplier or different formulation manufacturing site.

Key drivers of supplier shifts

• ANDA bioequivalence strategy may require different granulation/disintegration performance
• API sourcing changes tied to compliance, cost, or supply continuity
• Scale-up and validation outcomes at the contract manufacturer

Key Takeaways

• LIPOFEN is fenofibrate.
• Supplier identification for LIPOFEN requires product-specific labeling/manufacturer site data and, for API, DMF-linked API supplier information for the exact NDA/strength/dosage form.
• With only the drug name provided, a complete and reliable supplier list cannot be produced.

FAQs

1. How do I find the fenofibrate API supplier for a branded product in the US?
2. Where on FDA labeling can I verify the manufacturer and packager for a specific LIPOFEN strength?
3. Do fenofibrate API suppliers differ by strength or dosage form within the same brand?
4. How do ANDA applicants source fenofibrate API compared with branded marketers?
5. What evidence most reliably links a firm to fenofibrate API sourcing (labeling vs DMFs)?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.